THERMAGE THERMACOOL SYSTEM

K033942 · Thermage, Inc. · GEI · Feb 4, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033942
• Device Name: THERMAGE THERMACOOL SYSTEM
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids.

Device Story

Thermage ThermaCool System is an electrosurgical unit used in dermatologic and general surgical procedures. Device components include a main system unit, handpiece assembly (handpiece and treatment tip), coolant canister, coupling fluid, return pad, skin marking paper, cables, tubing, and optional footswitch. System delivers energy to tissue to achieve electrocoagulation and hemostasis; also used for non-invasive treatment of periorbital wrinkles and rhytids. Operated by healthcare professionals in clinical settings. Output provides thermal energy for tissue effect; clinical benefit includes surgical hemostasis and aesthetic improvement of periorbital skin.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, principle of operation, and materials compared to legally marketed predicate devices.

Technological Characteristics

Electrosurgical unit (21 CFR 878.4400). System includes handpiece, treatment tip, coolant canister, coupling fluid, and return pad. Operates via delivery of electrical energy for coagulation/hemostasis. Class II device.

Indications for Use

Indicated for patients requiring electrocoagulation and hemostasis in dermatologic and general surgical procedures, and for non-invasive treatment of periorbital wrinkles and rhytids.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• ThermaCool TC System (Model TC) (K021402)
• ThermaCool TC System (Model TC) (K013639)
• Thermage ThermaCool IIA System (K013034)
• Thermage ThermaCool II System (K003183)
• Thermage ThermaCool System (K000944)
• ThermaCool Coupling Fluid TF-2 (K030142)

Submission Summary (Full Text)

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FEB - 4 2004

K033942 1/2

## 510(k) Safety Summary 14.0

## Name of Device A.

| Trade Name: | Thermage ThermaCool System |
|----------------------|--------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and<br>Accessories (21 CFR 878.4400) |
| Contact Person: | Pamela M. Buckman, RN, MS<br>Vice President of Regulatory/Clinical Affairs |

### Predicate Devices B.

ThermaCool TC System:

| Device | Premarket Notification |
|---------------------------------|--------------------------|
| ThermaCool TC System (Model TC) | K021402, Cleared 11/5/02 |
| ThermaCool TC System (Model TC) | K013639, Cleared 1/29/02 |
| Thermage ThermaCool IIA System | K013034, Cleared 10/4/01 |
| Thermage ThermaCool II System | K003183, Cleared 12/8/00 |
| Thermage ThermaCool System | K000944, Cleared 7/19/00 |

Other ThermaCool System Accessories that are the subject of this 510(k) include:

| Accessory | Predicate | Premarket Notification |
|----------------|-----------------------------------|-------------------------|
| Coupling Fluid | ThermaCool Coupling<br>Fluid TF-2 | K030142, Cleared 2/3/03 |

{1}------------------------------------------------

K033442 2/2

#### C. Device Description

The Thermage ThermaCool System consists of the following components:

- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
- Accessory cables and tubing .
- Optional footswitch component ●

#### D. Indicated Use

The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids.

#### Technical characteristics E.

The technological characteristics of the Thermage ThermaCool System are substantially equivalent to those of the Thermage ThermaCool TC System, ThermaCool IIA System, ThermaCool II System, and ThermaCool System.

#### Summarv F.

By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently cleared for marketing in the United States.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers inside of a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Ms. Pamela M. Buckman, RN. MS Vice President of Regulatory/Clinical Affairs Thermage, Inc. 4058 Point Eden Way Hayward, California 94545-3721

Re: K033942

Trade/Device Name: Thermage ThermaCool System and Coupling Fluid Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 18. 2003 Received: December 19, 2003

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a prematket approval application (PM \). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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# Page 2 - Ms. Pamela M. Buckman, RN, MS

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN):

DEVICE NAME:

Thermage ThermaCool System and Coupling Fluid

INDICATIONS FOR USE:

The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Non-invasive treatment of periorbital wrinkles and rhytids.

| Prescription Use | X | OR | Over-The-Counter-Use | |
|------------------|---|----|----------------------|--|
| | | | | |

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

miriam Sand -------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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